Actively Recruiting
Phase 1B Study of Atezolizumab and Bevacizumab With Stereotactic Body Radiation Therapy for Unresectable Hepatocellular Carcinoma
Led by Massachusetts General Hospital · Updated on 2026-02-18
20
Participants Needed
3
Research Sites
260 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a combination of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for people with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be removed by surgery. This phase 1B study aims to understand how these treatments work together to treat and limit recurrence of this cancer. The FDA has approved atezolizumab and bevacizumab for this cancer, but not the combination including radiation therapy. Participants will receive atezolizumab and bevacizumab through intravenous infusions along with SBRT, a form of external beam radiation therapy. The study starts with a safety lead-in phase involving 6 participants to find the maximum tolerated dose of SBRT combined with the drugs, lasting 18 weeks with cycles every 3 weeks. Following this, up to 14 more participants will join the expanded study phase, continuing the drug infusions every 3 weeks with SBRT given in the first cycle. During the study, participants will undergo evaluations and follow-up visits including imaging and laboratory tests to monitor tumor response and side effects. Researchers will measure dose limiting toxicities, progression-free survival, overall survival, and changes in liver function over up to 5 years. Participants may stay in the study as long as treatments are safe and helpful, with long-term follow-up to assess outcomes and safety. The study is supported by Genentech and led by Massachusetts General Hospital.
CONDITIONS
Brief Title
Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of hepatocellular carcinoma unsuitable for surgery, transplant, or radiofrequency ablation
- Up to 5 lesions with total tumor size less than 20 cm and no lesion larger than 15 cm
- Measurable disease with at least one lesion 2 cm or larger by imaging
- Small volume extrahepatic disease allowed if less than 2 cm total size
- Prior transarterial chemoembolization or drug eluting beads allowed with 14-day washout
- ECOG performance status 0-1
- Child-Pugh A liver function
- Barcelona Clinic Liver Cancer stage Intermediate (B) or Advanced (C)
- No significant portal hypertension
- Adequate organ and marrow function based on recent lab tests
- No known HIV infection
- Documented hepatitis B and C virus status with controlled viral loads if applicable
- Women of childbearing potential must use contraception and have negative pregnancy test
- Men with partners of childbearing potential must use contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior systemic therapy for hepatocellular carcinoma
- Prior radiation to liver region causing excessive overlap with study radiation
- Prior selective internal radiotherapy or hepatic arterial Yttrium therapy
- Tumor extending into stomach, duodenum, small or large bowel
- Extrahepatic metastases larger than 2 cm total size
- Fibrolamellar, sarcomatoid, or biphenotypic hepatocellular carcinoma
- History of leptomingeal disease
- Gastrointestinal bleeding within 6 months
- Metastatic disease involving major airways or large mediastinal tumors
- Active or history of autoimmune disease except controlled hypothyroidism or type 1 diabetes
- History of lung inflammation or pneumonitis
- Active tuberculosis
- Significant cardiovascular or vascular disease
- Recent major surgery or trauma
- History of malignancy other than hepatocellular carcinoma within 5 years except low-risk cancers
- Severe infection or recent therapeutic antibiotic use
- Prior allogenic stem cell or organ transplant
- Clinically significant bleeding or clotting risk
- Recent use of full-dose anticoagulants or thrombolytics
- Recent biopsy or minor surgery before treatment
- History of gastrointestinal fistula, perforation, obstruction, or inflammatory processes
- Uncontrolled illness or infection
- Recent live attenuated vaccine use
- Severe allergy to study drug components
- Untreated or high-risk varices
- Moderate or severe ascites
- Serious wounds or ulcers
- History of hepatic encephalopathy
- Active co-infection of hepatitis B and C
- Known HIV infection
- Untreated or progressing brain metastases
- Recent high-dose aspirin or certain antiplatelet medication use
- Chronic daily NSAID use except low-dose aspirin
- Uncontrolled tumor-related pain
- Uncontrolled effusions requiring frequent drainage
- Uncontrolled hypercalcemia
- Recent investigational therapy
- Recent immunostimulatory or immunosuppressive therapy except specific exceptions
- Uncontrolled hypertension
- Prior hypertensive crisis or encephalopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks for safety lead-in, then continued treatment until study drugs are no longer safe or beneficial
Participants receive the combination of atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT). The treatment includes a safety lead-in phase of 6 cycles (18 weeks), followed by an expansion phase where treatment continues with atezolizumab and bevacizumab every 3 weeks.
Cycles every 3 weeks with SBRT delivered every 1-3 days during the first cycle
Duration - Up to 5 years
Participants are followed for up to 5 years after treatment to monitor progression-free survival, overall survival, and response rates.
Periodic follow-up visits during the 5-year period
Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jennifer Y Wo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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